Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

IZI 2017-07-05

Leica FL560

Applicant Leica Microsystems (Schweiz) AG

K-Number K170239

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OYE 2017-07-03

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

Applicant Becton, Dickinson and Company

K-Number K170974

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LLZ 2017-07-03

Enterprise Imaging XERO Viewer 8.1

Applicant Agfa Healthcare N.V.

K-Number K170434

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NLQ 2017-07-03

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K170955

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ONB 2017-07-03

Equashield Closed System drug Transfer Device (CSTD)

Applicant Equashield Medical , Ltd.

K-Number K170706

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OLO 2017-07-03

NavLock Trackers

Applicant Medtronic Navigation

K-Number K171267

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DQY 2017-07-03

YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up

Applicant Codman & Shurtleff, Inc.

K-Number K171653

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PMC 2017-07-03

DigniCap Scalp Cooling System

Applicant Dignitana AB

K-Number K170871

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ODP 2017-07-03

Gemini-C Hybrid Cervical Interbody System

Applicant Osseus Fusion Systems, LLC

K-Number K170844

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MOF 2017-07-01

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip

Applicant Asahi Intecc Co., Ltd.

K-Number K171613

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MQV 2017-06-30

FIBERGRAFT BG Matrix Bone Graft Substitute

Applicant Prosidyan, Inc.

K-Number K171284

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POD 2017-06-30

D2 Dressing

Applicant Z-Medica, LLC

K-Number DEN160012

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